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Blood test may spare kids from unnecessary CT scans after head injury

NCT ID NCT02855034

Knowledge-focused Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether measuring two proteins in the blood (S100B and copeptin) can help doctors decide if a child with a head injury needs a CT scan. Many children get CT scans that are normal, exposing them to radiation. The study enrolled 167 children aged 3 months to 15 years. However, the study was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to decide which children need a CT scan after head injury, reducing radiation exposure.
What could go wrong
The study was terminated early, so results may be incomplete. The biomarkers may not be accurate enough to replace CT scans in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

167 people

The number who actually took part.

Started

May 2016

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 15 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria for the Target Population: * Paediatric patients aged 3 months up to 15 years * Cranial trauma with indication of brain scanner according to risk of clinically important traumatic brain injury (high or intermediate risk), according the clinical prediction rule Pediatric Emergency Care Applied Research Network (PECARN) * Period of 6 hours of less after cranial trauma * Informed and written consent from one of the parents or legal representatives * Patient must be covered by a french social security scheme Inclusion criteria for the Control Population: * Paediatric patients aged 3 months up to 15 years admitted to the emergency room for whom a blood sample is required * Informed and written consent from one of the parents or legal representatives * Patient must be covered by a french social security scheme Exclusion criteria for the Target Population: * A pre-existing intracranial injury or malformation, or osteogenesis imperfecta * Coagulation disorder * Multiple accidental trauma * Evocative elements of mistreatment Exclusion criteria for the Control Population: * Cranial trauma ou suspicion of cranial trauma * brain pathology including migraines * Febrile syndrome * Chronic inflammatory pathology * Known bleeding disorder * Evocative elements of mistreatment

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

Contacts and locations

Locations

  • Montpellier University Hospital

    Montpellier, 34295, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.